December 05, 2017

FDA Offers Draft Guidance on E-Submissions of REMS Documents

The FDA recently released draft guidance describing how FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain submissions under new drug applications, abbreviated new drug applications and biologics license applications.

FDA Comments on Stakeholder Feedback

In the guidance, FDA describes three years of engagement and analysis of stakeholder feedback regarding REMS standardization. The agency’s findings were published as a report: “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS).” As the report describes, some stakeholders expressed concern about the clarity and consistency with which information about REMS materials and requirements are communicated to stakeholders. They told FDA that REMS materials and requirements may be difficult to locate, and that specific activities and requirements of various stakeholders (e.g., prescriber, pharmacist) are not always clearly outlined.

Some stakeholders expressed the need to have better ways to integrate REMS materials and procedures into their existing health information systems and health care delivery processes. Stakeholders also expressed the desire to avoid spending excessive time trying to locate, understand, and comply with different REMS requirements while ensuring safe use of drugs with REMS.

To help address these concerns, FDA intends to require applicants of NDAs, ANDAs, and BLAs to submit the content of their REMS documents in Structured Product Labeling (SPL) format. SPL can be used to capture and present REMS information in a format that is easily shared with stakeholders and readily incorporated into health information technology.

Structured Product Labeling

REMS documents will be required to be submitted in electronic format using Structured Product Labeling (SPL). SPL is a Health Level Seven (HL7) standard based on Clinical Document Architecture and HL7 Reference Information Model (RIM) accredited by the American National Standards Institute (ANSI) for the exchange of product information. Structured Product Labeling documents include a header and body. The header includes information about the document such as the type of product, author and versioning. The body of the document includes product information in both structured text and data element formats. The FDA uses SPL documents to exchange information covering a growing number of product related topics.

Requirements That Must Be Followed for Electronic Submission of the Content of REMS Documents

Under section 745A(a) of the FD&C Act, electronic submissions “shall be submitted in such electronic format as specified by [FDA].” This guidance addresses electronic submission requirements for certain documents that are part of a REMS. A REMS document, which is part of the REMS that is approved by FDA, concisely describes the goals and requirements of the REMS.

FDA has determined that the content of a REMS document must be submitted electronically in SPL format, using specifications outlined in the FDA Data Standards Catalog. REMS materials are all materials that are included as part of the REMS (e.g., communication and educational materials, enrollment forms, prescriber and patient agreements) that are also approved and enforceable, and are appended to the REMS document. REMS materials must be referenced in the SPL file. REMS supporting documents should not be submitted in SPL format.